FDA 510(k) Application Details - K030899

Device Classification Name System, Test, C-Reactive Protein

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510(K) Number K030899
Device Name System, Test, C-Reactive Protein
Applicant ABBOTT LABORATORIES
1920 HURD DR.
IRVING, TX 75038 US
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Contact LINDA MORRIS
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Regulation Number 866.5270

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Classification Product Code DCN
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Date Received 03/24/2003
Decision Date 07/02/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee IM - Immunology
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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